Study Evaluating AMG 386 in Adult Patients With Advanced Solid Tumors
This study has been completed.
Sponsor:
Amgen
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00102830
First received: February 3, 2005
Last updated: August 19, 2010
Last verified: August 2010
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Purpose
The purpose of this study is to test the safety, tolerability and pharmacokinetic (PK) profile of AMG 386 after intravenous administration in adult subjects with advanced solid tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Tumors |
Drug: AMG 386 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Primary Purpose: Treatment |
| Official Title: | A Phase 1 Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of AMG 386 in Adult Patients With Advanced Solid Tumors |
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- Adverse events, clinically significant changes in laboratory results, ECG, and vital signs, to be measured throughout the study.
- Pharmacokinetic Profile of AMG 386 - blood levels of AMG 386 to be measured throughout the study.
Secondary Outcome Measures:
- Changes in DCE-MRI imaging results measured at baseline, Week 1, and Week 4.
- Changes in blood levels of angiogenic cytokines measured at baseline, Day 3, Weeks 2, 4, 10, and every 8 weeks thereafter.
- Anti-AMG 386 antibody formation measured at baseline, weeks 2, 4, 6, and every 4 weeks thereafter.
- Tumor response measure by CT scan at baseline, Week 4, and every 8 weeks thereafter.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria: - Have evaluable disease - Must be able to undergo MRI evaluation:
- Must not have cardiac pacemakers or neurostimulators not specifically approved for use in the MRI environment;
- Must not have metal implants, other than those approved as safe for use in MRI;
- Must not be claustrophobic or have physical characteristics that will preclude undergoing MRI; - Subjects enrolling to the Dose Expansion Cohort must have at least one tumor that is amenable to DCE-MRI evaluation (e.g., greater than or equal to 3 cm lesion outside the thoracic cavity) - Have Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2 - Adequate hematologic, renal and hepatic function Exclusion Criteria: - Presence of untreated CNS metastasis or symptoms of brain metastases - Presence of leukemia or myelodysplastic syndrome - History of high-dose chemotherapy requiring bone marrow or peripheral stem cell support - Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure [NYHA greater than class II], uncontrolled hypertension [diastolic greater than 85 mmHg; systolic greater than 145 mmHg] or cardiac arrhythmia) - History of arterial thrombosis (i.e., stroke, transient ischemic attack or myocardial infarction) within 6 months of study day 1 - History of bleeding diathesis or hypercoagulopathy within 6 months of study day 1 - Active peptic ulcer disease or gastritis - Unresolved toxicities from prior anti-cancer therapy, excluding alopecia - Anti-tumor treatment within 3 weeks of study day 1. If anti-tumor treatment was an antibody therapy, the interval must be 6 weeks - Anticoagulation therapy, except a low dose of Coumadin™ (less than 2 mg) for prophylaxis against central catheter-related thrombosis - Major surgery within 4 weeks of study day 1 - History of allergic reaction to bacterially produced proteins - Known positive test for human immunodeficiency virus (HIV) infection, hepatitis C virus or chronic hepatitis B infection - Pregnant or breastfeeding - Not using adequate contraceptive precautions, in the judgment of the investigator
Contacts and Locations
More Information
Additional Information:
No publications provided by Amgen
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Global Development Leader, Amgen Inc. |
| ClinicalTrials.gov Identifier: | NCT00102830 History of Changes |
| Other Study ID Numbers: | 20040169 |
| Study First Received: | February 3, 2005 |
| Last Updated: | August 19, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Amgen:
|
Solid Tumor Metastatic Cancer Advanced Solid Tumors |
ClinicalTrials.gov processed this record on June 18, 2013